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NCT00789828 · OUTCOME

Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Seizure frequency
Interval / dispersion
Standard Deviation
Time frame
Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)

What was measured

Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was \< 18 hours.

Analysis population: The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.

Groups in this outcome

Everolimus (Core Period)

Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.

Placebo (Core Period)

Participants received oral dose of placebo matching to everolimus daily.

Everolimus (Extension Period)

Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Everolimus (Core Period)78
Placebo (Core Period)39
Everolimus (Extension Period)34

Reported measurements

Source class 1
Values in Seizure frequency · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)-1.246.12Not reportedNot reportedNot reported
Placebo (Core Period)-0.245.7Not reportedNot reportedNot reported
Everolimus (Extension Period)-6.079.719Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.12
        value
        -1.24
      2. group Id
        OG001
        spread
        5.7
        value
        -0.24
      3. group Id
        OG002
        spread
        9.719
        value
        -6.07
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      34
    units
    Participants
description
Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was \< 18 hours.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
    id
    OG000
    title
    Everolimus (Core Period)
  2. description
    Participants received oral dose of placebo matching to everolimus daily.
    id
    OG001
    title
    Placebo (Core Period)
  3. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
    id
    OG002
    title
    Everolimus (Extension Period)
param Type
MEAN
population Description
The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.
reporting Status
POSTED
time Frame
Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)
title
Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period
type
SECONDARY
unit Of Measure
Seizure frequency

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice